Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-27 @ 12:20 PM
Study NCT ID:
NCT04754204
Status:
COMPLETED
Last Update Posted:
2022-02-09
First Post:
2021-02-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mobile Cardiac Telemetry and Advanced Multi-Parameter Monitoring in Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 585}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-08', 'studyFirstSubmitDate': '2021-02-09', 'studyFirstSubmitQcDate': '2021-02-09', 'lastUpdatePostDateStruct': {'date': '2022-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biometric Data Associations to Arrhythmias', 'timeFrame': '30 days', 'description': 'MCT Data Sets'}, {'measure': 'Biometric Data Associations to Subject-Reported Symptoms', 'timeFrame': '30 days', 'description': 'MCT Data Sets'}, {'measure': 'Biometric Data Associations to Subject Wellness', 'timeFrame': '30 days', 'description': 'MCT Data Sets'}], 'secondaryOutcomes': [{'measure': 'Clinician Use of Biometric Data Associations to Arrhythmias', 'timeFrame': '30 days', 'description': 'Clinical Case Report Forms'}, {'measure': 'Clinician Use of Biometric Data Associations to Subject-Reported Symptoms', 'timeFrame': '30 days', 'description': 'Clinical Case Report Forms'}, {'measure': 'Clinician Use of Biometric Data Associations to Wellness Status of Subject', 'timeFrame': '30 days', 'description': 'Clinical Case Report Forms'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['cardiac', 'arrhythmia'], 'conditions': ['Cardiac Arrhythmia']}, 'descriptionModule': {'briefSummary': 'To determine the associations among biometric data, arrhythmias, subject-reported symptoms and subject wellness.', 'detailedDescription': 'The Arrhythmia Management System records rhythm, heart rate, subject-reported symptoms and multiple parameters that include respiration rate, activity and body posture. These biometric data could provide clinicians better insight into the context of the detected arrhythmias, subject-reported symptoms and wellness status. Hence, the purpose of the study to determine the associations among biometric data, arrhythmias, symptoms and subject wellness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult subjects, 21 years or older who:\n\n1. Require mobile cardiac telemetry monitoring for the detection of non-lethal cardiac arrhythmias\n2. Are without any cardiac implantable electronic devices, including loop recorders\n3. Are without wearable cardioverter defibrillator\n4. Are without Holter monitors, wearable event recorders, and other mobile cardiac telemetry devices at the same time\n5. Are not currently hospitalized\n6. Do not have any skin condition that would prevent them from wearing the AMS device\n7. Are not non-ambulatory\n8. Are not reporting to be pregnant\n9. Are not participating in another clinical study', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects who require monitoring for non-lethal cardiac arrhythmias\n* Subjects who have an indication for mobile cardiac telemetry (MCT) monitoring\n* Subjects 21 years of age or older\n\nExclusion Criteria:\n\n* Subjects with an implantable cardiac device such as left ventricular assistive device, pacemaker, implanted cardioverter defibrillator (ICD), cardiac resynchronization therapy device, subcutaneous ICD's, pressure monitors and loop monitors\n* Subjects with wearable cardioverter defibrillator, Holter monitors, wearable event recorders, and other mobile cardiac telemetry devices at the same time\n* Subjects currently hospitalized\n* Subjects with a skin condition preventing them from wearing the AMS device\n* Subjects who are non-ambulatory\n* Subjects who are self-reporting to be pregnant\n* Subjects participating in another study"}, 'identificationModule': {'nctId': 'NCT04754204', 'acronym': 'MAPS', 'briefTitle': 'Mobile Cardiac Telemetry and Advanced Multi-Parameter Monitoring in Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zoll Medical Corporation'}, 'officialTitle': 'Mobile Cardiac Telemetry and Advanced Multi-Parameter Monitoring in Patients Wearing a Novel Device', 'orgStudyIdInfo': {'id': '90D0234'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients indicated for Mobile Cardiac Telemetry Monitoring', 'description': 'Patients indicated for Mobile Cardiac Telemetry Monitoring while meeting inclusion/exclusion criteria and enrolled in sequential manner.', 'interventionNames': ['Device: Arrhythmia Management System (AMS)']}], 'interventions': [{'name': 'Arrhythmia Management System (AMS)', 'type': 'DEVICE', 'description': 'AMS records rhythm, heart rate, subject-reported symptoms, and multiple parameters that include respiration rate, activity and body posture.', 'armGroupLabels': ['Patients indicated for Mobile Cardiac Telemetry Monitoring']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93309', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Comprehensive Cardiovascular Medical Group', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '90813', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Cardiovascular Innovation and Research Center', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Heartbeat Cardiovascular Medical Group', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91307', 'city': 'West Hills', 'state': 'California', 'country': 'United States', 'facility': 'Interventional Cardiology Group', 'geoPoint': {'lat': 34.19731, 'lon': -118.64398}}, {'zip': '32086', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Flagler Hospital/Flagler Health', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '34476', 'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'facility': 'Cardiovascular Institute of Central Florida', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '32086', 'city': 'Saint Augustine', 'state': 'Florida', 'country': 'United States', 'facility': 'First Coast Heart and Vascular Center', 'geoPoint': {'lat': 29.89469, 'lon': -81.31452}}, {'zip': '46321', 'city': 'Munster', 'state': 'Indiana', 'country': 'United States', 'facility': 'Cardiovascular Research of Northwest Indiana', 'geoPoint': {'lat': 41.56448, 'lon': -87.51254}}, {'zip': '46321', 'city': 'Munster', 'state': 'Indiana', 'country': 'United States', 'facility': 'Cardiovascular Research of Northwest', 'geoPoint': {'lat': 41.56448, 'lon': -87.51254}}, {'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Jackson Heart Clinic', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '14227', 'city': 'Cheektowaga', 'state': 'New York', 'country': 'United States', 'facility': 'Trinity Medical', 'geoPoint': {'lat': 42.90339, 'lon': -78.75475}}, {'zip': '28401', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'PMG Research of Wilmington', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '37403', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Erlanger Health System', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '79109', 'city': 'Amarillo', 'state': 'Texas', 'country': 'United States', 'facility': 'ClinicalTex Research LLC d/b/a PharmaTex Research', 'geoPoint': {'lat': 35.222, 'lon': -101.8313}}, {'zip': '77339', 'city': 'Kingwood', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Cardiology Associates of Houston', 'geoPoint': {'lat': 30.05691, 'lon': -95.18349}}, {'zip': '75070', 'city': 'McKinney', 'state': 'Texas', 'country': 'United States', 'facility': 'Heart Rhythm Specialists', 'geoPoint': {'lat': 33.19762, 'lon': -96.61527}}, {'zip': '75071', 'city': 'McKinney', 'state': 'Texas', 'country': 'United States', 'facility': 'CardioVoyage', 'geoPoint': {'lat': 33.19762, 'lon': -96.61527}}, {'zip': '77505', 'city': 'Pasadena', 'state': 'Texas', 'country': 'United States', 'facility': 'Orion Medical Research', 'geoPoint': {'lat': 29.69106, 'lon': -95.2091}}, {'zip': '98166', 'city': 'Burien', 'state': 'Washington', 'country': 'United States', 'facility': 'Daniel W. Gottlieb, MD, PS', 'geoPoint': {'lat': 47.47038, 'lon': -122.34679}}, {'zip': '25702', 'city': 'Huntington', 'state': 'West Virginia', 'country': 'United States', 'facility': "St. Mary's Medical Center", 'geoPoint': {'lat': 38.41925, 'lon': -82.44515}}], 'overallOfficials': [{'name': 'Ramu Perumal, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Zoll Services LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zoll Medical Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}